AETOS Shoulder System

NCT06319911 | Recruiting DMC

• 1 other identifier: AETOS 2022.04
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization

Conditions

Shoulder Osteoarthritis; Shoulder Arthritis

Keywords

Shoulder; arthroplasty

Outcome Measures

Primary Outcomes (1)

• Implant Survivorship

  Implant survivorship at 2 years post operatively defined as absence of device removal or revision of any component

  2 years

Secondary Outcomes (14)

• Implant Survivorship at 6 months, 1 year, 3.5 years and 5 years

  6 months, 1 year, 3.5 years, and 5 years

• Radiographic Assessment - Glenoid Migration/Subsidence

  Day 0, 1 year, 2 years, and 5 years

• Radiographic Assessment - Glenoid Radiolucency

  Day 0, 1 year, 2 years, and 5 years

• Radiographic Assessment - Humeral Radiolucency

  Day 0, 1 year, 2 years, and 5 years

• Radiographic Assessment - Humeral Migration/Subsidence

  Day 0, 1 year, 2 years, and 5 years

Study Arms (2)

Primary Anatomic

Those subjects who have the AETOS implanted in the Primary Anatomic configuration

Device: AETOS

Primary reverse

Those subjects who have AETOS implanted in the Reverse configuration

Device: AETOS

Interventions

AETOS DEVICE

The AETOS Shoulder System will be implanted into the right or left shoulder in the anatomic or reverse configuration

Primary Anatomic; Primary reverse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females who are at least 18 years of age at the time of consent, are skeletally mature, and are indicated for primary anatomic or primary reverse will be enrolled in the study

You may qualify if:

• Patients must meet all the following criteria to be included in the study:
• Patient is at least 18 years of age at the time of consent and skeletally mature.
• Patient is undergoing a primary elective anatomic or reverse shoulder replacement surgery for one of the following indications:
• Rheumatoid arthritis, and/or
• Traumatic arthritis (Post Traumatic arthritis), and/or
• Non-inflammatory degenerative joint disease, and/or
• Correction of functional deformity.
• Patient is willing and able to accommodate all study-related procedures and visits detailed in the protocol \& cooperate in the standard of care post-operative therapy.
• Patient is geographically stable and willing to return to the study site for all follow-up visits.
• Patient has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation.

You may not qualify if:

• Patients who meet any of the following criteria will not qualify for participation in the trial:
• Patient has a contraindication to AETOS.
• Patient is undergoing a revision shoulder replacement surgery including total or partial arthroplasty.
• Patient is indicated for a Hemiarthroplasty.
• Patient has traumatic injury or a fracture.
• Patient has uncontrolled diabetes with a hemoglobin A1C of 7.5 or greater.
• Patient has comorbidities/conditions that preclude proper healing/fixation of the implant.
• Patient has poor quality or insufficient bone stock to support the implant.
• Patient has poor bone quality where there could be considerable migration of the implant and/or a chance of fracture.
• Patient has rapid joint destruction, marked bone loss or bone resorption (e.g., severe osteoporosis).
• Patient has osteomalacia.
• Patient has muscular, neurologic, or vascular deficiencies that may compromise the outcome of the shoulder replacement surgery.
• Patient has a known sensitivity, allergic reaction, and/or known allergies to one or more of the implanted materials.
• Patient has a distant foci of infection which may spread to the implant site, active local or systemic infection, sepsis, or osteomyelitis.
• Patient has an elevation of sedimentation rate, elevation of WBC count, or marked shift in WBC differential count unexplained by other disease.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

California Pacific Orthopedics

San Francisco, California, 94118, United States

RECRUITING

Western Orthopaedics

Denver, Colorado, 80210, United States

RECRUITING

Hughston Foundation

Columbus, Georgia, 31909, United States

RECRUITING

Center for Orthopedics and Neurosurgical Care

Bend, Oregon, 97701, United States

RECRUITING

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Study Officials

• Kolja Boese

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Central Study Contacts

Tammy Clark, MPH

CONTACT

3512269585; tammy.clark@smith-nephew.com

Karlie Morgan

CONTACT

5124967507; karlie.morgan@smith-nephew.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 20, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2030
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)